Unpacking the Shortcomings of the Vaccine Injury Compensation Program

The National Childhood Vaccine Injury Act of 1986 established the Vaccine Injury Compensation Program (“VICP”) as a replacement regime for vaccine-related injuries. The VICP is funded by a seventy-five cent tax on each vaccine dose. Individuals alleging vaccine-related injuries file a petition, which is adjudicated by a special master of the U.S. Court of Federal Claims. Petitioners may seek damages for, inter alia, health care and rehabilitation costs (past and anticipated), though damages for pain and suffering or death are capped at $250,000. The law provides broad legal immunities for vaccine manufacturers, including preemption of tort claims for design or warning defects. In 2011, the U.S. Supreme Court interpreted the preemption provision to include design defects where the vaccine manufacturer failed to incorporate a safer alternative design.

The VICP maintains a Vaccine Injury Table that lists compensable injuries—these are deemed “on-table” injuries, and causation is presumed. All other injuries are deemed “off-table” injuries, and petitioners have the burden of proving causation. This distinction is significant; between 1999 and 2014, six vaccines were added to the table, and none had an on-table injury. During that same time period, the percent of petitions alleging off-table injuries increased from 25% to 98%. Importantly, the statute does not mandate that the data needed to meet the causation bar be collected by manufacturers or disclosed to the public; moreover, FDA regulations have not filled this legal gap. To the contrary, as officials from the FDA and CDC explain, “no active effort is made to search for, identify and collect information [on vaccine adverse events], but rather information is passively received from those who choose to voluntarily report.” Given the challenges in demonstrating causation and the lack of data to analyze causation, the net result is a large decrease in awarded claims and a large increase in uncompensated harms.

There can be no question that vaccines are a public health triumph. At the same time, however, with statistical certainty a small number of vaccinees will suffer catastrophic injuries or death. As health policy expert Michelle Mello has argued, vaccinations involve a high stakes gamble where the overwhelming majority will benefit but no one knows (or can predict with reliable certainty) who will suffer harm. Over the past three decades the VICP has adjudicated over 14,000 petitions, and thus there is ample data from which to evaluate the VICP. Herein steps Nora Freeman Engstrom. Her article, A Dose of Reality for Specialized Courts: Lessons from the VICP, is an elegant and comprehensive investigation of the VICP, and her findings highlight several troubling trends.

As Engstrom details, “[t]he picture is bleak. The VICP has simply failed to offer compensation as consistently, as quickly, as easily, or as simply as it proponents had predicted.” (P. 1675.) For example, the average vaccine-injury petition takes longer to adjudicate that the average tort claim alleging medical malpractice. The Government Accountability Office has underscored the fact that the expectations of the VICP “have often not been met,” while patient advocacy groups have lambasted the VICP as “a betrayal of the promise that was made to parents about how the compensation program would be implemented.” (Pp. 1675-76.) Even the VICP’s Chief Special Master, who served in that role for over two decades, publicly stated that “litigating causation cases has proven the antithesis of Congress’s desire for the Program.” (P. 1676.) Moreover, due to the structure of the law (particularly, the preemption provisions), in cases where an injury resulted because a vaccine manufacturer failed to use a safer alternative design, the manufacturer “is not in any way affected if a decision is made to compensate the petitioner.” (P. 1671.) Compensation awards are derived entirely from the Vaccine Injury Trust Fund (not from the vaccine manufacturer), and special masters do not have the legal authority to require a new vaccine design.

The adversarial nature of the petitions is particularly troubling, and not just for questions of causation. This is despite the fact that Congress directed that the VICP “provide for a less-adversarial, expeditious, and informal proceeding.” (P. 1711, n.376.) As Engstrom details, government attorneys dig into the minutia of claims; in one case the government argued that $150 was too much to spend per year on wheelchair maintenance, while in another the government argued that a 14-year old girl with vaccine-related “profound mental retardation and severe spastic quadriplegia” was not entitled to $40 high-top tennis shoes. (P. 1692.) In a case where a child was crippled by the Hepatitis B vaccine, the government haggled over whether a competent nurse could be obtained for $50 or $60 per hour, and tried to limit the hours that the child could be assisted by a nurse to five hours per day (the family indicated they needed the nurse for eight hours). Meanwhile, the vaccine injury trust fund has a “bulging surplus” of over $3.6 billion, and in many years the interest on the trust fund is sufficient to pay out all awarded claims.

Replacement regimes like the VICP, Engstrom explains, “are the go-to weapon in serious tort reformers’ collective arsenals.” (Pp. 1640-41.) Such regimes—which jettison tort law in favor of some version of a “no-fault” compensation mechanism—have been proposed for dozens of scenarios, including injuries resulting from medical malpractice, motor vehicles, firearms, lead paint, and nuclear accidents. By closely examining the VICP, Engstrom sounds the alarm bells for specialized courts, particularly specialized health courts. As she highlights, “before the traditional tort system is abandoned . . . there must be substantial grounds to ensure confidence in an alternative institutional mechanism that would serve as its replacement.” (P. 1717.) Engstrom’s arguments are compelling, and must be taken seriously.

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